HNAB (.305)Hana Biosciences (HNAB) Marqibo and ASCO, Full Analysis: A Comparison in Second Line Salvage Therapy
May 13th, 2010 by admin Leave a reply »
Hana Biosciences (HNAB):
Marqibo and ASCO
Today I am going to write a brief write-up on Hana Biosciences and their lead product Marqibo. The company recently reported Topline results from the Phase II trial of the drug in ALL patients.
So first thing first, what is Marqibo exactly?
Marqibo is an experimental drug and is basically Vincristine sulfate injection, which is an approved chemotherapy medication that has been used for many years to treat different types of cancer, including leukemias (cancers of the white blood cells). It damages the cancer cells through its effect on microtubulins that are essential during cell division. Marqibo is a liposomal formulation of vincristine sulfate injection. In this formulation, vincristine is placed inside of oil droplets called liposomes. The liposomal formulation results in a slow, steady release of vincristine, exposing the cancer cells to vincristine continuously over specified time. The drug received orphan drug status in 2007, which would give it 7 years of market exclusivity if approved.
What is the Lead Indication?
Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
Adult Lymphoblastic Lymphoma and the Philadelphia Chromosome Explained
ALL is an aggressive (fast-growing) type of leukemia (blood cancer) in which too many lymphoblasts (immature white blood cells) are found in the blood and bone marrow. Also called acute lymphoblastic leukemia and acute lymphocytic leukemia. The NCI estimates that there are 5,760 new cases each year of the disease and about 1,400 patients die each year as well. Sixty percent to 80% of adults with ALL can be expected to attain complete remission status following appropriate induction therapy. Approximately 35% to 40% of adults with ALL can be expected to survive 2 years with aggressive induction combination chemotherapy and effective supportive care during induction therapy (appropriate early treatment of infection, hyperuricemia, and bleeding).
A few studies, including a Cancer and Leukemia Group B study, that use intensive multiagent approaches suggest that a 50% 3-year survival is achievable in selected patients, but these results must be verified by other investigators.
Appropriate initial treatment, usually consisting of a regimen that includes the combination of vincristine, prednisone, and anthracycline, with or without asparaginase, results in a complete remission rate of up to 80%. Patients who experience a relapse after remission can be expected to succumb within 1 year, even if a second complete remission is achieved.
The Philadelphia chromosome-negative population is important in treatment options because it helps identify if patients will be responsive to treatments. Patients that have Philadelphia chromosome POSITIVE have been found to be much more resistant to treatments for ALL, while patients with Philadelphia Chromosome negative are more responsive to treatments. In fact, in a study published back in 2001, patients that were Philadelphia-positive (Ph+) ALL displayed a poor outcome since median LFS was 7 months with only 13% of survival at 3 years (journal here).
So how does Marquibo Stand up to Current Treamtents for Patients in their Second Relapse?
Data on these patients isn’t exactly easy to come by, but never fear GekkoWire readers, I was able to scoop up some highly relevant data so you can draw some comparisons to Marqibo. In a 2008 study the journal Cancer published the following findings (journal here). The outcome of adults with acute lymphocytic leukemia (ALL) who undergo second salvage therapy has been characterized poorly. This is important with regard to investigational approaches aimed at helping this subset of patients. The objectives of the current study were to predict outcomes and determine the prognostic factors associated with second salvage therapy in patients with ALL. METHODS: In this study, 288 patients were analyzed who received second salvage therapy for ALL at the authors’ institution. RESULTS: Overall, 53 patients (18%) achieved a complete response (CR). The median remission duration was 7 months and the median survival was 3 months.
So how does Marqibo Line Up?
We know that in the topline data that patients in the Phase II trial of Marqibo that are relapsed twice had a complete response rate of 21% (data here), which is in line with the above statistics. Additionally, patients taking Marqibo had an overall survival rate of about 7.3 months in the complete response group. It appears that Marqibo is providing a competitive remission rate compared to the treatments used in the Cancer study, however it isn’t clear what the overall survival benefit is in the entire Marqibo trial. You see, in the survival statistics Hana included only the patients that had achieved a complete response, not everybody in the entire trial. This is in contrast to the previously cited Cancer study where they include everybody in the survival statistics, even poor responders. What is comparable though is that in the Cancer study, of the patients that achieved a Complete response the duration of remission was 7 months and this could be used as a comparable statistics to the median survival of 7.3 months in patients taking Marqibo.
Additionally, Nelarabine was recently approved in the Philadelphia chromosome positive groups with complete response data around 20%-40%. So it appears that so far Marqibo is falling in line with what is known about salvage therapy in 2nd relapse patients. Investors should remember to keep a special eye on the overall survival data, complete response rates, and remission duration data at this year’s ASCO and compare them to the numbers in the Cancer 2008 study I outlined above.
On a final note investors should be aware that Hana’s abstract that will be presented at this year’s 2010 ASCO meeting will be available on May 20, 2010 (here) and this should represent a pivotal point for your decisions. Remember to click some advertisements to help support the site and remember you should be looking for the abstract titled: #6507: Phase II study of marqibo in adult patients with refractory or relapsed philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia.
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